ISO 22000:2005 Awareness Training

About the Course

Aim
To know Food safety Management system
Audit Methodology and To develop
Auditing skills
Instructions
• Facilities
- Wash Room

• This is a non smoking venue.

• Courtesy (mobile phones, etc.) - Mobile

to be switched off during the course.
Requested to use mobile during Lunch
and Tea breaks only.

• Stipulated time for Tea & Lunch

Breaks
COURSE MATERIAL

• ISO 22000:2005 Standard

Delegate Introductions
PARTICIPANTS INTRODUCTION
Information to be obtained from Delegates

• Full name
• Name of organization for which they working/previously worked
• Position and role within the organization
• Career background
• Auditing experience – first, second or third party
• Personal objective for attending the course
• Any information which the auditor should know to be able to establish successful
communication with auditee.
 Session-2

Definition & Terminology

 Food Safety
Assurance that food will not cause harm to the
consumer when it is prepared and/or eaten
according to its intended use.
Reference-
CAC/RCP 1-1969, Rev.4- 2003 ( 2.3 Definitions)
 Definitions and Terminology
 Control: To manage the conditions of an operation to maintain compliance with established
criteria.
 Critical limit: Criterion which separates acceptability from unacceptability
 Control measure: Action or activity that can be used to prevent or eliminate a food safety
hazard or reduce it to an acceptable level

 Critical Control Point: A point, step or procedure at which control can be applied to prevent
or eliminate a hazard.
 CCP Decision Tree: A sequence of questions asked to determine whether a control point is
critical control point.
 Deviation: Failure to meet a critical limit

 HACCP Plan: The written document based upon principles of HACCP that delineates the

procedures to be followed to ensure the control of a specific process or procedure.

 Food safety hazard: biological, chemical or physical agent in food, or condition of food,
with the potential to cause an adverse health effect

 Food safety policy: Overall intentions and direction of an organization related to food safety
as formally expressed by top management
 Monitor: To conduct a planned sequence of observations or measurements to assess whether
a CCP is under control and to produce an accurate record for future use in verification.

 Operating Limits: Criteria more stringent than critical limits that are used by an operator to
reduce that risk of contamination. For example, if a certain chemical concentration is required
to control a hazard, the operating limit is generally set above the minimum concentration
needed to ensure effective treatment.
 Risk: An estimate of the likely occurrence of a hazard.
 Severity: The seriousness of a hazard (if not properly controlled).
 Validation: Verification focused on collecting and evaluating scientific and technical
information to determine if the HACCP plan, when properly implemented, will effectively
control the hazards.

 Verification: The use of methods, procedures or tests, in addition to those used in

monitoring, that determine if the HACCP system complies with the HACCP plan and / or
whether the plan needs modification.
modification
 Correction : Action to eliminate a detected nonconformity

 Corrective action: Action to eliminate the cause of a detected nonconformity or other

undesirable situation

 Flow diagram: Schematic and systematic presentation of the sequence and interactions of
steps

 Food Chain: Coverage all the stages from primary food production to the final consumer
 End product: Product that will undergo no further processing or transformation by the
organization
 Updating: Immediate and/or planned activity to ensure application of the most recent
information
 Prerequisite Programme PRP: Basic conditions and activities that are necessary to maintain a
hygienic environment throughout the food chain (3.2) suitable for the production, handling and
provision of safe end products (3.5) and safe food for human consumption

 Operational PRP/ Operational Prerequisite Programme : Identified by the hazard analysis as

essential in order to control the likelihood of introducing food safety hazards (and/or the
contamination or proliferation of food safety hazards in the product(s) or in the processing
environment
 Session-3

HACCP
Food Safety Management System
Requirements for any organization in Food
Chain
 WHY Food Safety ?
HACCP based food safety system has become a necessity in the present situation
due to the following reasons :

Fast Food Addiction

Deterioration of quality and scarcity of water
Poor monitoring of Animal health
Inadequate disposition of waste
Use of synthetic manure, insecticides and pesticides
Consumer Safety
How to Achieve Food Safety

Application of HACCP at all the stages

of production
Introduction to HACCP
H Hazard
A Analysis
C Critical
C Control
P Point

A system which identifies , evaluates and controls

hazards which are significant for food safety
Origin of HACCP
Way back in 1960s
• National Aeronautical and Space Application (NASA) Center
wanted safe food for astronauts on space flights

• Pillsbury Corporation took the challenge of producing safe food

by developing the HACCP system.

• The Codex Alimentarius by publishing THE CODEX GENERAL

PRINCIPLES OF FOOD HYGIENE recommends a HACCP-based
approach to enhance food safety
Logical Sequence of Application of HACCP
Step 1: Assemble HACCP Team

Step 2: Describe Product and identify intended use

Step 3 : Construct a flow diagram

Step 4 : On Site confirmation of Flow Diagram

Step 5 : Seven Principals of HACCP

 Seven Principles of HACCP
 Conduct hazard analysis
 Identify critical control points (CCPs)
 Establish critical limits

 Establish a system to monitor control of the CCP

 Establish corrective actions

 Establish procedures for verification

 Establish documentation and record keeping

 Session-4

ISO 22000:2005
Food Safety Management System
Requirements for any organization in Food
Chain
4. Food safety management requirements

Establish, document, implement and maintain an effective Food Safety

Management System and update it.

Define the Scope of Food Safety Management System.

Products categories.

Processes and production sites.

Documentation requirements

Food safety policy & related objectives

Documented procedures required by the standard

Records required by the standard

Documents needed to ensure effective development, implementation and

updating of the Food Safety Management System
Required documented procedures

 Document control (4.2.2)

 Record control (4.2.3)

 Nonconformity control

 Corrections (7.10.1)

 Corrective action (7.10.2)

 Withdrawals (7.10.4)

 Internal Audit (8.4.1)

4.2.2 Control of documents

Documented procedure defining controls for Food Safety Management

System required documents:

 Approval for adequacy before use

 Review/update as necessary & re-approval

 Changes and current revision status clearly identified

4.2.2 Control of Documents

 Relevant version available at points of use

 Documents remain legible and readily identifiable

 Documents of external origin are identified and their distribution

controlled

 Prevent use of obsolete documents, and identify if retained

4.2.3 Control of records

 Maintained to demonstrate conformance to requirements and the

effective operation of the Food System Management System

 System-level procedure for identifying, storage, retrieval, protection,

retention times and disposal
5.Management responsibility
5.1 General

• Top Management to provide evidence of its commitment to

development & implementation of the Food SMS & continually
improving its effectiveness

• How???
 Top Management
I’m out
 Showing food safety is supported by of here!
business
 Objectives
 Communicating the importance of meeting
customer/statutory/ regulatory requirements
 Establishing the food safety policy

 Holding management reviews

 Ensuring availability of resources

5.2 Food safety policy

Top management to ensure it:

Is appropriate to the role of organization in food chain.

Conforms with both statutory and regulatory and with agreed food safety
requirements of customers
Is communicated, implemented and maintained at all levels of organization
Is reviewed for continuing suitability
Adequately addresses communication
Is supported by measurable objectives.
objectives
5.3 Food safety management system
planning

Top Management to ensure planning conducted to:

 Meet the overall requirements and food safety objectives

 Ensure system integrity during changes

5.4 Responsibility and authority

 Top Management to ensure that Responsibilities & Authorities are defined

& communicated

 All personnel have the responsibility to report problems with the Food
Safety Management System to identified person(s).

 That designated personnel shall initiate and record action.

action
5.5 Food Safety Team Leader

 Manage a food safety team

 Ensure relevant training and education of

team

 Ensure the Food SMS is established,

implemented, maintained & updated

 Reporting effectiveness and suitability to

top management
5.6 Communication

 External communication

 Supplier and contractors

 Customers or consumers

 Statutory and regulatory authorities

 Other impacted organization on food Safety Management System

 Known food safety hazards, needed to be controlled by other

organizations.
5.6 Communication (Cont.)

 Internal communication.

 Food safety team is informed of changes in food Safety Management System.

 Food safety team shall ensure the updating of the Food Safety Management
System.
5.7 Emergency preparedness and response

 Procedure to manage potential emergency situation and accidents that can

impact food safety

 Role of the organization in the food chain.

5.8 Management review
 Top management reviewing Food Safety Management Safety to ensure
suitability, adequacy & effectiveness

 Defined intervals

 Is there a need to amend the Food Safety Management System , food

safety policy.
5.8 Management review (cont…)

Review information to:

 Follow up issues from previous reviews
 Analysis results of verification activities
 Changing circumstances that affect to food safety.
 Emergency situation, accident and withdrawals
 Reviewing results of system updating activities.
 Review of communication activities, including customer fed back
 External audits or inspection
 Data shall be presented in link to objectives
5.8 Management review (cont…)

Output shall include decisions and actions related to:

 Assurance of food safety

 Improvement of Food SMS

 Resource needs

 Revision of Food safety policy and objectives

6.Resource Management
6.1 Provision of Resource

 Provide the adequate resources for established,

implementation, maintenance and updating Food Safety Management
System
6.2 Human resources

 All personnel shall be competent

 Have appropriate education training skills and experience

 Maintain agreement or contract of external experts, defining the

responsibility and authority.
authority
6.2 Human resources

 Identify competence needs

 Provide training or other action

 Train personnel who responsible for monitoring, correction and corrective

actions
 Evaluate effectiveness of training or other actions

 Ensure that personnel are aware of activity/contribution

 Ensure effective communication

 Training or development records

6.3 Infrastructure & 6.4 Work environment

 Provide infrastructure and work environment

 needed to implement this Standard.
7. Planning and realization of Safe
Products
7.1 General

 Plan & develop necessary processes for realization of safe products

 Implement, operate and ensure the effectiveness of planned activities,

Including PRP, operational PRP and HACCP plan
Typical Hazards & Hazards Classification

Typical Hazard

 Biological

 Chemical

 Physical
Biological Hazard
Sources of hazards – Biological

 Raw materials
 Animals
 Environment
 Staff
Sources of hazards – chemical
 Veterinary Medicines
 Fertilizers
 Packaging chemical compounds
 Hazardous gases and aerosols
 Cleaning and disinfection detergents
Sources of hazards – physical
 Glass  Equipment
 Metal particles
 Facilities
 Hair
 Raw materials
 Nail
 Packages
 Stones  Environment
 Dust/ dirt  Personnel
 Ionizing radiation
Factors necessary for the growth of
microbes
“ FAT TOM”
 Food- Which provides Nutrients and energy

 Acidity

 Temperature

 Time

 Oxygen

 Moisture
7.2 Prerequisite programmes (PRPs)

7.2.1 Establish, implement and maintain PRP to assist in controlling

 Likelihood Food safety hazards thru work environment

B / C / P contamination, cross contamination between
product

 Food safety hazard level in product and process environment

7.2 Prerequisite programmes (PRPs)
FOOD POISONING There are several types of Food Poisoning

Bacteria Food Poisoning is the most common type :

 7.2 Prerequisite programmes (PRPs)
BACTERIOLOGY – BACTERIA AND FOOD
• Bacteria are microscopic organisms which occur in a
• Number of different forms. They are usually measured in
• Microns () A typical bacterium would be approx. 1 micron long

The smallest object visible to the naked eye is 80-90 micr. ,1 Micron=1/1000 mm
Bacteria occur in huge number throughout the environment including some living on
or in plants and animals. The Vast Majority are harmless but some are
PATHOGENIC i.e. they may cause serious illness or even death.
Bacteria reproduces by splitting in two every few minutes
7.2 Prerequisite programmes (PRPs)

BACTERIOLOGY –

Examples of pathogenic bacteria

Salmonellae live Clostridium perfringens
in guts of animal is present in soil,dust and
and people human& animal excreta

Boils & Infected cuts , the

nose and mouth may contain
Staphylococcus aureus
 7.2 Prerequisite programmes (PRPs)
BACTERIOLOGY – Conditions Limiting Bacterial Growth
Any given bacterium will only
bacterial
multiply over limited range of temp.
Outside this range colonies will not
&
grow but may survive for long period
In Order to multiply bacteria require
certain atmospheric conditions.
Food packaging such as cans
excludes bacteria from the food and
surrounds it in atmosphere in which
most bacteria will not multiply
Water is required for
Growth.Low moisture food
products such as dried fruit
biscuits will not spoil if kept dry
Some bacteria are
Unable to multiply in
foods with high sugar
content and this is the
basis of the preservation
of soft fruits in form of
7.2 Prerequisite programmes (PRPs)
FOOD POISONING -EXAMPLES OF FOOD POISONING
BACTERIA SOURCE OF INFECTION TYPICAL SYMPTOMS TYPICAL ILLNESS
Salmonella Animals (pets and pests) Pain in Abdomen Symptoms start :
milk ,eggs, raw Diarrhoea, 12-36 hrs after eating
meat ,contaminated water, Vomiting,Fever Symptoms last :
infected persons Several Days –one week
*Clostridium Excrement, raw meat , Pain in Abdomen Symptoms start :
Perfingens soil, pest infestation Diarrhoea, 12-30 hrs after eating
Symptoms last :12-48 hrs
*Staphyloco Human nose , mouth Pain in abdomen, Symptoms start :
ccus Aureus infectedBoils and cuts , Vomiting 1-6 hrs after eating
raw milk from infected animals Lower temperature Symptoms last :6-24 hrs

*Escherichia Human excrement, sewage Pain in abdomen, Symptoms start :

coli Diarrohea, Vomiting 12-24 hrs after eating
Fever Symptoms last : 1-5 days
7.2 Prerequisite programmes (PRPs)

Cover following areas

 Premises Design
 Equipments
 Equipments Cleaning and Sanitation
 Staff Recruitment ,Protective Clothing & Training
 Personal Hygiene
 Pest Control
 Temperature Control
 Transportation
7.2 Prerequisite programmes (PRPs)

Design and Facilities - Location

1. Establishment
Establishments should be located away from
 environmentally polluted areas and industrial
activities which pose a serious threat of contaminating
food
 areas subject to flooding unless sufficient safeguards are
provided
7.2 Prerequisite programmes (PRPs)

Equipments
Equipment should be sited so that it:

 permits adequate maintenance and

cleaning;

 functions in accordance with its intended use

 facilitates good hygiene practices, including monitoring

7.2 Prerequisite programmes (PRPs)

EQUIPMENTS
All materials used in equipment in food areas must be non- toxic,
resistant to corrosion and easily cleaned.
E.g.plastic or stainless steel handled knives are better than those
with wooden handles

All surfaces should be smooth and non-porous as this makes cleaning easier
Stainless steel has been found to be particularly suitable for use in the
construction of tables, shelving, and other equipment in food areas.
Cutting boards should be made of polypropylene which resists staining and
damage whilst being easy to clean
7.2 Prerequisite programmes (PRPs)

EQUIPMENTS
All equipment and machinery must be so designated that it is easy to
maintain and that there is little chance that foreign bodies such as
lubricating greases ,nuts ,bolts etc. will find their way into foodstuffs.

All equipment must be subject to regular planned

maintenance Peeling paint and missing components pose
the risk of foreign Body contamination Faulty equipment
such as refrigerator may permit the multiplication of pathogenic
bacteria. Records should be kept of the maintenance history of large
items of equipments
 7.2 Prerequisite programmes (PRPs)

EQUIPMENTS
Care must be taken to avoid cross contamination occurring if
equipment is used for both raw and processed foodstuffs without
adequate washing. Colour coding of items such as cutting boards
helps to minimise this risk

When not in use all food equipment must be kept in

Clean , well lit , well maintained storage area.
7.2 Prerequisite programmes (PRPs)
CLEANING AND DISINFECTION
REASONS FOR CLEANING
 Removal of food deposits which permit micro-organisms to multiply
 Removal of refuse which harbors and attracts pests
 Removal of debris which might otherwise contaminate food
 Creates a pleasant working environment
 Projects a good image to consumers
Cleaning is EVERYBODY’S responsibility , not just that of designated kitchen
cleaners. Those preparing food should get into habit of CLEAN AS YOU GO
Spillages and debris should not be permitted to remain until the end of a shift but
instead should be cleaned up as soon as possible
7.2 Prerequisite programmes (PRPs)
CLEANING AND DISINFECTION
A comprehensive cleaning programme must be drawn up Which specifies
the frequency and types of cleaning operation to be carried out in particular
areas.
In addition to daily operations the cleaning programme must also include
“deep” cleaning of the interiors of equipment and plant. Such work must
be scheduled to take place when Food production has ceased and no
foodstuffs are exposed

Disinfection reduces pathogens populations so that they can not cause disease. It
does not necessarily kill bacterial spores. HEAT and CHEMICAL DISINFECTANTS
are used to disinfect surfaces
7.2 Prerequisite programmes (PRPs)
CLEANING AND DISINFECTION

Factors affecting disinfectant choice :- Bad Cleaning and disinfection

Amount of soiling Procedures can actually be
 Types of surfaces More dangerous than no
 types of pathogens Cleaning at all since they may
 time in contact with Cause cross contamination,

pathogens e.g. inappropriate usage of

hose
7.2 Prerequisite programmes (PRPs)

CLEANING AND DISINFECTION

The risk of CROSS CONTAMINATION can be
lessened by careful planning. The use of colour
coded disposable cleaning Cloths is recommended since , for example , they make it
easy to tell which cloth is used to clean the wall and which to clean a food preparation
surface.

All cleaning programmes must be backed up by frequent

And thorough hygiene inspections to assess the standard
Of work undertaken and to highlight potentially dangerous
Situations.
7.2 Prerequisite programmes (PRPs)

STAFF RECRUITMENT , PROTECTIVE CLOTHING , TRAINING

When seeking recruits catering managers should select

candidates who :
-have a high standard of personal hygiene
-have a sound basic education and are keen to learn
- are mature & self disciplined , free from infection
Following a successful initial interview the candidate must be Given
a thorough medical examination by a physician Who, amongst
other things , will check for a history of food Poisoning ,
food borne illness and TB
7.2 Prerequisite programmes (PRPs)
STAFF RECRUITMENT , PROTECTIVE CLOTHING , TRAINING
All food handlers must be provided with protective clothing

which:
- Prevent human hair & skin, clothing fibres , street dust etc.
contaminating foodstuff
- must include headgear to cover scalp hair
- must include safety footwear with non-slip soles and protective toecaps
- must be laundered daily ,not be worn outdoor and keep in clean locker
- must be completely cover personnel clothing (shirts, woolen jumpers etc.)worn
underneath
- must be worn completely so that it cannot become entangled in machinery.
7.2 Prerequisite programmes (PRPs)

STAFF RECRUITMENT , PROTECTIVE CLOTHING , TRAINING

All newly recruited food handlers must undergo an induction
course which emphasizes their responsibilities in maintaining
good standards. Initially they must work under close , direct
supervision.

All food handlers must be subject to regular training and retraining.

They have an absolute obligation to report Any potentially infectious
conditions such as diarrhea and sore throats to their supervisors
immediately and To co-operate with any necessary
medical follow-up.
7.2 Prerequisite programmes (PRPs)
Personal Hygiene- Staff Behavior & Habits
Food handlers must make frequent use of wash hand basins (not dish Washing sinks) supplied
with hot Water and suitable liquid soap
Hands must be wash
 Before entering Food handling Area
 After visiting toilet
 After handling Raw Food & before Handling Cooked food
 After handling Refuse
 Whenever they become soiled during the day’s work
 After wiping one’s nose or touching ones face
• Food handlers should report any deficiencies in availability of water ,soap, towels, air dry
etc. to their supervisors
 7.2 Prerequisite programmes (PRPs)
Personal Hygiene- Staff Behavior & Habits
Food Handlers must not wear
 Strong Perfumes which might taint foodstuff
 Nail varnish , false nails or false eyelashes which might contaminate food
 Items of jewelry which might fall into foodstuff or become entangled in machines
Smoking in or Near Food areas is totally forbidden due to
 the risk of contamination with ash & saliva-laden cigarette end
 the fact that smokers tend to cough
 smokers habit of frequently moving their hands near their mouth
 7.2 Prerequisite programmes (PRPs)

Personal Hygiene- Staff Behavior & Habits

 All Boils must be reported to supervisors and the food handlers Concerned
excluded from production area
 Those with septic cuts must not continue to work , it should be water proof
dressing with brightly colored to detect easily
 Food handlers must be aware of the risks to hygiene posed by many common
habits
 7.2 Prerequisite programmes (PRPs)
PEST CONTROL
A Number of pests spread pathogenic micro-organism and their presence in a food
premises therefore poses the risk of an outbreak of food poisoning or a food borne
diseases
Pests can cause extensive damage to structures and commodities Ex. Range from
electrical wiring gnawed by rodents to store Foodstuffs being fed upon by beetles and
moths.
Pests can also contaminate foodstuff with their corpses , Dropping, fur,etc. Another
important reason for controlling Pests is the understandably strong aversion the public
has to the presence of pests near foodstuffs
7.2 Prerequisite programmes (PRPs) Cont.

 Be appropriate to organization need

 Be appropriate to size, type and nature of products

 Be implemented across the entire production system

 Be approved by food safety team

 Shall identify related statutory and regulatory requirements

7.2 Prerequisite programmes (PRPs) Cont.
7.2 Prerequisite programmes (PRPs) Cont.

 Construction and layout of building and utility

 Lay-out of premises, workspace & employee facilities

 Supplies of air, water, energy and other utilities Waste, sewage disposal
 Equipment, accessibility for cleaning, maintenance

 Management of purchased material, supplies, disposals and handling of

products
7.2 Prerequisite programmes (PRPs) Cont.

 Measures for prevention of cross contamination

 Cleaning and sanitizing

 Pest control

 Personnel hygiene

 Other aspects, as appropriate

 PRP verification shall be planned and modified as necessary

7.3 Preliminary steps to enable hazard
analysis
 Collect information needed

 Appoint food safety team, multi-disciplinary knowledge & experienced

 Raw materials, ingredients, product-contact materials

 Characteristics of end products

 Intended use

 Flow diagrams, process step and control measure

7.4 Hazard analysis

• Determine which hazards need to be controlled, degree of control

combination of control measures

• Hazard identification and determine acceptable levels, based on :

 Preliminary collected information & data Experience

 External information

 Information from food chain

 7.4.2 Hazard identification

 Consider to Preceding and following step of specified operation

 Process equipment, utilities and surrounding Preceding and following links in

food chain

 Determine acceptable level

 Justification and result shall be recorded

7.4.3 Hazard assessment

Conduct the hazard assessment to determine whether

 Its elimination or reduction to acceptable Levels

 Its control is need to meet the defined acceptable level

 Describe the methodology used and record

 Session-5

ISO 22000:2005
Food Safety Management System
Hazard and Risk
 Hazard and risk
Food Safety Hazard
Biological, chemical or physical agent in food, or condition of food, with the
potential to cause an adverse health effect
OR
A biological, chemical or physical agent in, or condition of, food with the
potential to cause an adverse health effect
Codex Alimentarius, 2003
Food Safety Risk
The function of the probability of the adverse effect (harm) and the severity of
that effect
Risk Matrix Control Plan

RISK LEVEL ACTION AND TIMESCALE

TRIVIAL No action is required and no documentary records need to be
kept.
TOLERABLE No additional controls are required. Consideration may be given
to a amore cost-effective solution or improvement that imposes
no additional cost burden. Monitoring is required to ensure that
the controls are maintained.
MODERATE Efforts should be made to reduce the risk, but the costs of
prevention should be carefully measured and limited.

SUBSTANTIAL GMPs and GHPs are applied, special measures for keeping the
risks within tolerable limits are applied. The effect is controlled
through measurements and if necessary the process is
considered as a CCP
INTOLERABLE The process is controlled as a CCP
Risk Assessment Matrix

Slightly harmful Harmful Extremely

Harmful
Trivial Risk Tolerable Risk Moderate
Highly unlikely Risk

Tolerable Risk Moderate Risk Substantial

Unlikely Risk

Moderate Risk Substantial Risk Intolerable

Likely Risk
 Hazard Assessment
In conducting the hazard assessment, the following should be taken into consideration:
• The sources of the hazard (e.g. where and how it can be introduced into the
product and/or its environment);
• The probability of occurrence of the hazard (e.g. qualitative and/or quantitative
prevalence, such as frequency of occurrence and the typical levels, highest
possible levels and/or statistical distribution of levels);
• The nature of the hazard (e.g. ability to multiply, deteriorate and produce
toxins);
• The severity of the adverse health effects that can be caused by the hazard.
Likelihood (Probability):

The probability of such hazard occurring is measured using the following parameters:
Frequent (Daily) - 5
Likely (Weekly) -4
Occasional (Monthly) - 3
Unlikely (Yearly) -2
Very Unlikely (Not yet observed) -1
Severity (Impact):
The severity or impact of such hazard on the human health is measured using the
following parameters:
Critical (Death) -5
High (Hospitalization/illness) - 4
Medium (Absence from work) - 3
Low (Complaint/economic loss) - 2
 Critical
5 5 10 15 20 25

High Significant Hazards

(controlled by OPRP
4 4 8 12 16 20 ≥10 or HACCP Plan)

Medium
3 3 6 9 12 15
Hazard
Impact/Severity
Non-Significant
Low
Hazards (controlled
2 2 4 6 8 10 ≤9 by PRP)

Negligible
1 1 2 3 4 5

1 2 3 4 5

Never Unlikely Occasional Likely Frequent

Hazard Occurrence Probability

HAZARD ANALYSIS : Frozen PUD Shrimp
Assessment Criteria for Control Measures Parameters

a) Control measure effect on identified food safety hazards relative to the strictness applied 1. Not eliminate completely
2. Reduce or control to meet acceptable level
3.Reduce to within acceptable level or eliminate
the hazard completely

b) Control measure feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable 1. No feasibility
immediate corrections) 2. Has limitation
3. Feasible
c) Control measure place within the system relative to other control measures 1. First
2. Middle
3. Final measure
d) the likelihood of failure in the functioning of a control measure or significant processing variability 1. High ,
2. Medium
3. Low
e) the severity of the consequence (s) in the case of failure in its functioning 1. Negligible effect
2. Complaint
3. Health implications
f) whether the control measure is specifically established and applied to eliminate or significantly reduce 1. No
the level of hazards(s) 2. Somewhat
3. Definitely
g) synergistic effects (i.e. interaction that occurs between two or more measures resulting in their 1.No
combined effect being higher than the sum of their individual effects) 2.Somewhat
3.Yes
Justification for categorization of control measure
into HACCP plan and OPRP
Assessment of Control Measures

4. Management &
Categorization
1. Selected 3. Total score HACCP
Combination of 2. Assessment Criteria (a+b+c+d+e+f+ OPRP Plan
Control Measures (Levels of effectiveness) g) (CCP)

a b c d e f g

Scoring Parameters

1 1 1 1 1 1 1 7 ≤ 14

3 3 3 3 3 3 3 21 >14
 Worksheet for Assessment and categorization of
control measures
Categorization of the
Assessment Criteria (Levels of effectiveness) control measures (CCP or
OPRP )
Total
Description Selected Scoring Parameters (1, 2, 3) acc. to guidance on scoring (Control
Hazard OPRP CCP
No. of Process Combination of parameters Measure
Description
Steps Control Measures Effectivity
)
a b c d e f g ≤ 14 >14

Adherence to Food
Hygiene Practices/
Biological RM Inspection/ 2 2 1 2 1 1 3 12 OPRP
Approved Supplier/
Raw Supplier Certificate
1
Material
Receiving RM Inspection/
Approved Supplier/
Chemical Supplier Certificate/ 3 2 2 2 3 3 3 18 CCP
Lot Rejection
7.4.4 Selection and assessment of
control measures

 Select appropriate combination of control measures

 Categorized selected control measures whether manage thru Operational

PRP or HACCP plan
7.5 Establishing the operational
prerequisite programme

 Document operational PRP

 Food safety hazard(s) to be controlled

 Control measure

 Monitoring procedures

 Correction and corrective action to be taken

 Responsibilities and authorities

 Record of monitoring
OPRP PLAN FORM Product : Raw Fish
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
OPRP Significant Control Correction Records Verification
Hazards Measures Monitoring and
Corrective
What How Frequency Who Action
(s)

Raw Biological:- Proper Temperatu Using For Every Purchase Reject the 1. Raw 1.Weekly
material Pathogenic micro Chilling of re of the calibrated 500 kg of supervisor lot if the materials verification of
Receiving organisms may be the Raw raw thermomete raw material Inspection the process and
present Material material r materials temp > 4° Record records By QA
with Ice and during C 2.Training Personnel
Keeping the Receipt 2.Inform Record 3. Training
temp and Train 3.Supplier Record
with in 4° C the Evaluation Verification by
supplier on n QA Mgr
significanc Record
e of RM
Temp
3. Re
evaluation
of Supplier
7.6 Establishing the HACCP plan

 Document HACCP plan

 Identification of critical control points

 Determine critical limit for CCP

 System for monitoring of CCP

 Action when monitoring results exceed critical limit

 HACCP PLAN
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)
CCP Significant Control Critical Limits Correction and Records Verification
Hazards Measures Monitoring Corrective
Action(s)
What How Frequency Who

Packing Physical – Metal No metal Presenc Autom Continuous- Produc Separate the Metal 1) Daily
(Metal Metal Detection pieces above e of atically For each and tion packet with Detector verification of
Detection Fragments 1.5 mm for Fe; metal by the every final Staff metal Monitoring the sensitivity of
Process) 2.5 mm for fragme machi packets of contamination, Record; metal detector
non-Fe; nts in ne- materials segregate the Preventive by QA Manager
2.00 mm for the Metal metal Maintena 2) Weekly
SS finished Detect pieces and nce Verification of
product or attach with Record; the maintenance
identification Calibration process by the
tags. Record of technical
Check for the Metal manager
defective parts Detector; 3) Calibration
and proper Training Record
maintenance / Record;
replacement of Correction
all the food and
contact Corrective
surfaces, Action
training of the Record
technical
personnel and
their evaluation
7.7 Updating of preliminary information
and document specifying the PRP and
HACCP plan
Updating the following information , if necessary

 Product chart

 Intended use

 Flow diagram

 Process step

 Control measure
7.8 Verification planning

 Verification activities shall confirm that PRP are implemented

 Input to hazard analysis is updated

 Effective of operational PRP and HACCP plan

 Hazard levels are within acceptable level

 Other procedure are implemented and effective

7.9 Traceability system

 Traceability system for product lot and their relation to batch of raw
material, processing and delivery record

 Able to identify incoming material from immediate suppliers and initial

distribution route of end product
7.10 Control of nonconformity

Corrections
 Identify and assessment affected end product to determine proper handling
 Review of the corrections carried out

Corrective actions

 Eliminate cause of detected N/C

 Prevent recurrence
 Bring the process or system back into control
7.10 Control of nonconformity

 Handling of potentially unsafe product

 To prevent the N/C product from entering the food chain

 N/C product shall be held until they have been evaluated

 Notify interested parties and initiate a withdrawal

7.10 Control of nonconformity

 Evaluation for release

 N/C product shall only be released as safe when

 Evidence of effective control measure, other than monitoring system.

 Evidence of complies with performance intended

 Result of sampling, analysis or either verification shows product complies

acceptable level
7.10 Control of nonconformity
 Disposition of N/C products

 Reprocessing or further processing to acceptable levels

 Destruction or disposal as waste Withdrawals

 Appoint authority personnel to initiate and execute the withdrawal

 Notify to interested parties

 Handling of withdraw product

 Procedure sequence of action to be taken

8. Validation, verification and improvement
of the Food Safety Management System

8.1 General

 Plan & implement

 Processes needed to validate control measures

 To verify and improve the Food Safety Management System

8.2 Validation of control measure
combinations

 Validate the control measures are capable to

control the Hazard

 Modify the control measures, as necessary.

8.3 Control of measuring & monitoring

To ensure valid results, devices are:

 Calibrated/adjusted prior to use or at specified intervals against devices

traceable to national/international standards if not, define basis for
calibration

 Identified & calibration status defined

 Safeguarded from adjustments

8.3 Control of measuring & monitoring

 Protected from damage & deterioration during handling, maintenance &

storage

 Assess & record previous results’ validity & take action when device
found not conforming to requirements

 Record calibration & verification results

 Software validated prior to use & when required.

8.4 Food safety management system
verification
8.4.1 Internal Audit
 Verify Food Safety Management System is complying & effectively
implemented
 Planned based on status, importance and previous results
 Independent auditors
 Documented procedure
 Timely corrective action by relevant mgt.
 Follow-up
8.4.2 Evaluation of individual verification
results

 Systematic evaluate the individual results of planed verification

 Take action to achieve the require conformity

8.4.3 Analysis of results of verification
activities

 Analyse the results of verification activities, incl. Internal / External audit

 To confirm overall performance of system.

 To identify need for updating / improving the Food SMS

 To identify trends of potential unsafe products Information for internal

audit
 To provide evidence the effectiveness of correction and corrective action
8.5 Improvement

8.5.1 Continual improvement

 Continually improve Food Safety Management System effectiveness through use

of various sources of information:

 Communication, management review, internal audit, verification activities,

validate result, corrective action, etc.
8.5.2 Updating the Food Safety
Management System

 Continually update the food Safety Management System

 Consider whether it is necessary to review hazard analysis, PRP and HACCP

plan

 As the input for management review.